Description of chart:

Issuance of an EUA by the FDA Commissioner requires several steps under section 564 of the FD&C Act. First, one of the four following determinations must be in place:

The Department of Defense (DoD) Secretary issues a determination of military emergency or significant potential for military emergency

The Department of Homeland Security (DHS) Secretary issues a determination of domestic emergency or significant potential for domestic emergency.

The Department of Health and Human Services (HHS) Secretary issues a determination of public health emergency or significant potential for public health emergency

The DHS Secretary issues a material threat determination

After one of the above four determinations is in place, the HHS Secretary can issue a declaration that circumstances exist to justify issuing the EUA. This declaration is specific to EUAs and is not linked to other types of emergency declarations.

The FDA Commissioner, in consultation with the HHS Assistant Secretary for Preparedness and Response (ASPR), Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH), can then issue the EUA, if criteria for issuance under the statute are met. FDA publishes public notice of each EUA that is issued in the Federal Register.

The last step in the process is termination of declaration and EUA, if appropriate and needed.

“Extreme electromagnetic incidents caused by an intentional electromagnetic pulse (EMP) attack or a naturally occurring geomagnetic disturbance (GMD, also referred to as “space weather”) could damage significant portions of the Nation’s critical infrastructure, including the electrical grid, communications equipment, water and wastewater systems, and transportation modes.

The impacts are likely to cascade, initially compromising one or more critical infrastructure sectors, spilling over into additional sectors, and expanding beyond the initial geographic regions.

EMPs are associated with intentional attacks using high-altitude nuclear detonations, specialized conventional munitions, or non-nuclear directed energy devices. Effects vary in scale from highly local to regional to continental, depending upon the specific characteristics of the weapon and the attack profile. High-altitude electromagnetic pulse attacks (HEMP) using nuclear weapons are of most concern because they may permanently damage or disable large sections of the national electric grid and other critical infrastructure control systems.

Similarly, extreme geomagnetic disturbances associated with solar coronal mass ejections (when plasma from the sun, with its embedded magnetic field, arrives at Earth) may cause widespread and long-lasting damage to electric power systems, satellites, electronic navigation systems, and undersea cables. Essentially, any electronics system that is not protected against extreme EMP or GMD events may be subject to either the direct “shock” of the blast itself or to the damage that is inflicted on the systems and controls upon which they are dependent. For these reasons, the potential severity of both the direct and indirect impacts of an EMP or GMD incident compels our national attention. …..”

The Merchant Marine Act of 1920, also known as the Jones Act, requires shipments between ports of the United States to be carried out exclusively by vessels built and operated by Americans. That prevents Puerto Rico from receiving shipments from foreign countries like Jamaica, even though it may be cheaper and faster than shipping from the continental U.S.

CPG 201 provides a four-step process for conducting a Threat and Hazard Identification and Risk Assessment. Developing an understanding of its risks from natural, technological, and human-caused threats and hazards, allows a community to make informed decisions about how to manage risk and develop needed capabilities.

The United States and the global aviation community face an adaptive and agile enemy. Terrorist groups continue to target passenger aircraft, and we have seen a “spider web” of threats to commercial aviation as terrorist pursue new attack methods. Based on these concerns, the Department of Homeland Security (DHS) is working to raise the baseline of global aviation security to keep the traveling public safe, in coordination with our international partners.

Change to Global Aviation Security Requirements

In light of evaluated intelligence, Secretary of Homeland Security John Kelly has determined it is necessary to implement enhanced security measures for all commercial flights to the United States. These measures, both seen and unseen, include enhanced screening of passengers and electronic devices as well as heightened security standards for aircraft and airports.

Countries: 105

Airports: 280 (approximate number as it will vary based on seasonal airports)

Total airlines: 180

Average daily flights: 2,100

Passengers: 325,000 average daily passengers

Enhanced Security Measures and Timeline

The enhanced security measures include but are not limited to:

Enhancing overall passenger screening;

Conducting heightened screening of personal electronic devices;

Increasing security protocols around aircraft and in passenger areas; and

Over the course of the next several weeks and months, DHS/TSA will work with aviation stakeholders to ensure these enhanced security measures are fully implemented. Those stakeholders who fail to adopt these requirements with certain timeframes run the risk of additional security restrictions being imposed.

International Flights Bound for the United States

These enhanced security measures will help to secure all commercial flights departing from 280 airports that serve as last points of departure to the United States.

OHA anticipates the public health impact of biological attacks, chemical releases, pandemics and infectious disease threats, and disasters to help prepare the nation to respond and rebound. Our expertise supports DHS operations, its workforce, and the preparedness of public health and medical communities.

OHA advises DHS leadership about health security issues, guides DHS policies to keep its workforce safe, and coordinates stakeholders at all levels of government to prepare for, respond to, and recover from the public health consequences of national threats and hazards.

OHA helps inform federal, state, and local decision-making about high consequence biological threats with biosurveillance programs that give early warnings for a rapid response to contain and limit the impact.

OHA helps communities nationwide prepare for a chemical or biological attack and build their own capacity to respond and recover.

Divisions

The Workforce Health and Medical Support Division – leads health protection and medical oversight activities for the DHS workforce and coordinates with stakeholders nationwide to strengthen the emergency medical response system. OHA guides DHS medical services with medical expertise, oversight, credentialing, protocols, and standards. OHA medical and veterinary experts guide the department on health threats to ensure a ready and resilient workforce. And OHA collaborates with federal, state, and local emergency medical services stakeholders to ensure we can work together in a crisis.